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1.
MMWR Recomm Rep ; 73(2): 1-8, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38833414

ABSTRACT

No vaccines and few chemoprophylaxis options exist for the prevention of bacterial sexually transmitted infections (STIs) (specifically syphilis, chlamydia, and gonorrhea). These infections have increased in the United States and disproportionately affect gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW). In three large randomized controlled trials, 200 mg of doxycycline taken within 72 hours after sex has been shown to reduce syphilis and chlamydia infections by >70% and gonococcal infections by approximately 50%. This report outlines CDC's recommendation for the use of doxycycline postexposure prophylaxis (doxy PEP), a novel, ongoing, patient-managed biomedical STI prevention strategy for a selected population. CDC recommends that MSM and TGW who have had a bacterial STI (specifically syphilis, chlamydia, or gonorrhea) diagnosed in the past 12 months should receive counseling that doxy PEP can be used as postexposure prophylaxis to prevent these infections. Following shared decision-making with their provider, CDC recommends that providers offer persons in this group a prescription for doxy PEP to be self-administered within 72 hours after having oral, vaginal, or anal sex. The recommended dose of doxy PEP is 200 mg and should not exceed a maximum dose of 200 mg every 24 hours.Doxy PEP, when offered, should be implemented in the context of a comprehensive sexual health approach, including risk reduction counseling, STI screening and treatment, recommended vaccination and linkage to HIV PrEP, HIV care, or other services as appropriate. Persons who are prescribed doxy PEP should undergo bacterial STI testing at anatomic sites of exposure at baseline and every 3-6 months thereafter. Ongoing need for doxy PEP should be assessed every 3-6 months as well. HIV screening should be performed for HIV-negative MSM and TGW according to current recommendations.


Subject(s)
Centers for Disease Control and Prevention, U.S. , Doxycycline , Post-Exposure Prophylaxis , Sexually Transmitted Diseases, Bacterial , Humans , Doxycycline/therapeutic use , United States , Male , Female , Sexually Transmitted Diseases, Bacterial/prevention & control , Anti-Bacterial Agents/therapeutic use , Sexual and Gender Minorities
2.
Clin Infect Dis ; 74(Suppl_2): S152-S161, 2022 04 13.
Article in English | MEDLINE | ID: mdl-35416973

ABSTRACT

Trichomonas vaginalis is likely the most prevalent nonviral sexually transmitted infection, affecting an estimated 3.7 million women and men in the United States. Health disparities are prominent in the epidemiology of trichomoniasis, as African Americans are >4 times more likely to be infected than persons of other races. Since publication of the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines, additional data have bolstered the importance of T. vaginalis infection sequelae in women, including increased risk of human immunodeficiency virus (HIV) acquisition, cervical cancer, preterm birth, and other adverse pregnancy outcomes. Less is known about the clinical significance of infection in men. Newly available diagnostic methods, including point-of-care assays and multiple nucleic acid amplification tests, can be performed on a variety of genital specimens in women and men, including urine, allowing more accurate and convenient testing and screening of those at risk for infection. Repeat and persistent infections are common in women; thus, rescreening at 3 months after treatment is recommended. In vitro antibiotic resistance to 5-nitroimidazole in T. vaginalis remains low (4.3%) but should be monitored. High rates of T. vaginalis among sexual partners of infected persons suggest a role for expedited partner treatment. A randomized controlled trial in HIV-uninfected women demonstrated that multidose metronidazole 500 mg twice daily for 7 days reduced the proportion of women with Trichomonas infection at 1 month test of cure compared with women receiving single-dose therapy (2 g). The 2-g single-dose oral metronidazole regimen remains the preferred treatment in men.


Subject(s)
HIV Infections , Premature Birth , Sexually Transmitted Diseases , Trichomonas Infections , Trichomonas Vaginitis , Trichomonas vaginalis , Centers for Disease Control and Prevention, U.S. , Female , HIV Infections/diagnosis , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Infant, Newborn , Male , Metronidazole/therapeutic use , Pregnancy , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/drug therapy , Sexually Transmitted Diseases/epidemiology , Trichomonas Infections/diagnosis , Trichomonas Infections/drug therapy , Trichomonas Infections/epidemiology , Trichomonas Vaginitis/diagnosis , Trichomonas Vaginitis/drug therapy , Trichomonas Vaginitis/epidemiology , United States/epidemiology
5.
MMWR Recomm Rep ; 70(4): 1-187, 2021 07 23.
Article in English | MEDLINE | ID: mdl-34292926

ABSTRACT

These guidelines for the treatment of persons who have or are at risk for sexually transmitted infections (STIs) were updated by CDC after consultation with professionals knowledgeable in the field of STIs who met in Atlanta, Georgia, June 11-14, 2019. The information in this report updates the 2015 guidelines. These guidelines discuss 1) updated recommendations for treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis; 2) addition of metronidazole to the recommended treatment regimen for pelvic inflammatory disease; 3) alternative treatment options for bacterial vaginosis; 4) management of Mycoplasma genitalium; 5) human papillomavirus vaccine recommendations and counseling messages; 6) expanded risk factors for syphilis testing among pregnant women; 7) one-time testing for hepatitis C infection; 8) evaluation of men who have sex with men after sexual assault; and 9) two-step testing for serologic diagnosis of genital herpes simplex virus. Physicians and other health care providers can use these guidelines to assist in prevention and treatment of STIs.


Subject(s)
Sexually Transmitted Diseases/therapy , Centers for Disease Control and Prevention, U.S. , Humans , United States
6.
MMWR Recomm Rep ; 68(5): 1-20, 2020 01 03.
Article in English | MEDLINE | ID: mdl-31899459

ABSTRACT

This report (hereafter referred to as STD QCS) provides CDC recommendations to U.S. health care providers regarding quality clinical services for sexually transmitted diseases (STDs) for primary care and STD specialty care settings. These recommendations complement CDC's Sexually Transmitted Diseases Treatment Guidelines, 2015 (hereafter referred to as the STD Guidelines), a comprehensive, evidence-based reference for prevention, diagnosis, and treatment of STDs. STD QCS differs from the STD Guidelines by specifying operational determinants of quality services in different types of clinical settings, describing on-site treatment and partner services, and indicating when STD-related conditions should be managed through consultation with or referral to a specialist. These recommendations might also help in the development of clinic-level policies (e.g., standing orders, express visits, specimen panels, and reflex testing) that can facilitate implementation of the STD Guidelines. CDC organized the recommendations for STD QCS into eight sections: 1) sexual history and physical examination, 2) prevention, 3) screening, 4) partner services, 5) evaluation of STD-related conditions, 6) laboratory, 7) treatment, and 8) referral to a specialist for complex STD or STD-related conditions.CDC developed the recommendations by synthesizing relevant, evidence-based guidelines and recommendations issued by other experts; reviewing current practice in the United States; soliciting Delphi ratings by subject matter experts on STD care in primary care and STD specialty care settings; discussing the scientific evidence supporting the proposed recommendations at a consultation meeting of experts and institutional stakeholders held November 20, 2015, in Atlanta, Georgia; conducting peer reviews of draft recommendations and supporting evidence; and discussing draft recommendations and supporting evidence during meetings of the CDC/Health Resources and Services Administration Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment STD Work Group. These recommendations are intended to help health care providers in primary care or STD specialty care settings offer STD services at their clinical settings and to help the persons seeking care live safer, healthier lives by preventing and treating STDs and related complications.


Subject(s)
Quality Assurance, Health Care , Sexually Transmitted Diseases/prevention & control , Centers for Disease Control and Prevention, U.S. , Humans , Practice Guidelines as Topic , United States
7.
Clin Infect Dis ; 71(Suppl 1): S1-S3, 2020 06 24.
Article in English | MEDLINE | ID: mdl-32578867

ABSTRACT

The articles in this supplement address key questions on syphilis diagnostics, provide reference tables of test performances, and discuss optimal specimens and knowledge gaps. Laboratory-developed genetic direct detection tests could be most useful at the point of care and add to the currently available serologic methods of nontreponemal and treponemal tests.


Subject(s)
Clinical Laboratory Techniques/standards , Syphilis , Treponema pallidum , Antibodies, Bacterial , Centers for Disease Control and Prevention, U.S. , Humans , Syphilis/diagnosis , Syphilis/epidemiology , Syphilis Serodiagnosis , Treponema pallidum/genetics , United States
8.
Sex Transm Dis ; 47(6): 412-418, 2020 06.
Article in English | MEDLINE | ID: mdl-32413019

ABSTRACT

BACKGROUND: With increasing rates of sexually transmitted infections in the United States, there is a critical need to educate health professionals on the prevention, diagnosis, and treatment of sexually transmitted infections. The National Sexually Transmitted Disease Curriculum (NSTDC, https://www.std.uw.edu) is a free, online curriculum, funded by the Centers for Disease Control and Prevention. The purpose of this article is to evaluate the reach, utilization, and engagement of users with the curriculum. METHODS: Data on NSTDC utilization was collected for 24 months after the February 1, 2017 launch. For all users, Google Analytics was used to determine total number of users, geographic location, age and sex, and average session duration. For registered users, additional data analysis included work-role, demographics, and completion of self-study modules, check-on-learning questions, and question banks. User satisfaction was measured on a 5-point Likert scale. RESULTS: During the evaluation period, 136,270 individual users accessed the NSTDC, including 24,652 registered users. Among all registered users, 10,660 (43.2%) were registered nurses, 2810 (11.4%) physicians, 4942 (20.1%) Advanced Practice Nurses and Physician Assistants, and 6213 (25.2%) nonclinicians. Among registered users, 18,533 (75.2%) completed at least 1 module, 7898 (32.0%) completed all 7 modules, and 19,804 (80.4%) answered optional check-on-learning questions. Median satisfaction with the content was (5) very satisfied (interquartile range, 4-5). CONCLUSIONS: The NSTDC is a free, guideline-based, online curriculum with novel dual functionality that has achieved extensive reach with a broad array of health professionals who engage deeply with the material. The wide usage of NSTDC demonstrates the need for high-quality, unbiased, free content in user-focused formats.


Subject(s)
Computer-Assisted Instruction/instrumentation , Curriculum , Education, Distance/statistics & numerical data , Health Personnel/education , Internet/statistics & numerical data , Sexually Transmitted Diseases , Humans , United States/epidemiology
9.
MMWR Morb Mortal Wkly Rep ; 69(50): 1911-1916, 2020 Dec 18.
Article in English | MEDLINE | ID: mdl-33332296

ABSTRACT

Sexually transmitted infections (STIs) caused by the bacteria Neisseria gonorrhoeae (gonococcal infections) have increased 63% since 2014 and are a cause of sequelae including pelvic inflammatory disease, ectopic pregnancy, and infertility and can facilitate transmission of human immunodeficiency virus (HIV) (1,2). Effective treatment can prevent complications and transmission, but N. gonorrhoeae's ability to acquire antimicrobial resistance influences treatment recommendations and complicates control (3). In 2010, CDC recommended a single 250 mg intramuscular (IM) dose of ceftriaxone and a single 1 g oral dose of azithromycin for treatment of uncomplicated gonococcal infections of the cervix, urethra, and rectum as a strategy for preventing ceftriaxone resistance and treating possible coinfection with Chlamydia trachomatis (4). Increasing concern for antimicrobial stewardship and the potential impact of dual therapy on commensal organisms and concurrent pathogens (3), in conjunction with the continued low incidence of ceftriaxone resistance and the increased incidence of azithromycin resistance, has led to reevaluation of this recommendation. This report, which updates previous guidelines (5), recommends a single 500 mg IM dose of ceftriaxone for treatment of uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydial infection has not been excluded, concurrent treatment with doxycycline (100 mg orally twice a day for 7 days) is recommended. Continuing to monitor for emergence of ceftriaxone resistance through surveillance and health care providers' reporting of treatment failures is essential to ensuring continued efficacy of recommended regimens.


Subject(s)
Gonorrhea/drug therapy , Practice Guidelines as Topic , Administration, Oral , Ceftriaxone/administration & dosage , Centers for Disease Control and Prevention, U.S. , Chlamydia Infections/complications , Chlamydia Infections/drug therapy , Chlamydia trachomatis , Coinfection/drug therapy , Doxycycline/administration & dosage , Evidence-Based Medicine , Gonorrhea/complications , Humans , Injections, Intramuscular , United States
10.
Sex Transm Dis ; 46(1): 9-17, 2019 01.
Article in English | MEDLINE | ID: mdl-29994936

ABSTRACT

PURPOSE: Trichomoniasis is the most prevalent nonviral sexually transmitted infection (STI) in the United States. It can present with vaginitis in women and urethritis in men, but is most often asymptomatic or occurs with minimal symptoms. It is associated with other STIs, adverse pregnancy outcomes and pelvic inflammatory disease. For these reasons, health care provider awareness of trichomoniasis is of public health importance. METHODS: To assess practitioner knowledge, attitudes, and practices concerning trichomoniasis management, the American College of Obstetricians and Gynecologists conducted an online survey in 2016 of its members, and we analyzed results from 230 respondents. RESULTS: We note discrepancies between practice and recommendations among surveyed providers: a minority of respondents routinely screen human immunodeficiency virus (HIV)-positive patients for trichomoniasis (10.7%, "most of the time"; 95% confidence interval [CI], 6.7-15.8; 33.0%, "always"; 95% CI, 26.5%-40.0%), treat trichomoniasis in HIV-positive patients with the recommended dose of metronidazole 500 mg twice a day for 7 days (25.8%; 95% CI, 20.0%-32.3%), or retest patients diagnosed with trichomoniasis 3 months after treatment (9.6%; 95% CI, 6.1%-14.3%). Only 29.0% (95% CI, 23.0%-35.5%) retreat with metronidazole 500 mg twice a day for 7 days in patients who have failed prior treatment. CONCLUSIONS: Screening for and treatment of trichomoniasis in HIV-positive patients, and retesting and retreatment for trichomoniasis in the general population appear to be suboptimal. Continuing education for providers is needed for this common but "neglected" STI.


Subject(s)
Health Knowledge, Attitudes, Practice , Physicians/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Trichomonas Infections/diagnosis , Antiprotozoal Agents/administration & dosage , Education, Medical, Continuing , Female , Gynecology , Humans , Male , Metronidazole/administration & dosage , Middle Aged , Obstetrics , Sexually Transmitted Diseases/parasitology , Surveys and Questionnaires , Trichomonas Infections/drug therapy , United States , Urethritis/parasitology , Vaginitis/parasitology
11.
Sex Transm Dis ; 46(5): 279-286, 2019 05.
Article in English | MEDLINE | ID: mdl-30985632

ABSTRACT

BACKGROUND: We evaluated single oral dose of delafloxacin versus single intramuscular ceftriaxone in participants with uncomplicated urogenital gonorrhea (primary objective). Secondary objectives included the efficacy, safety, and tolerability of delafloxacin versus ceftriaxone for uncomplicated urogenital, rectal, and/or pharyngeal gonorrhea. METHODS: In this open-label, multicenter study, 460 participants at 25 study centers were randomized (2:1) to receive a single 900-mg oral dose of delafloxacin or 250-mg intramuscular ceftriaxone. Neisseria gonorrhoeae culture, nucleic acid amplification test, and clinical responses were evaluated. The primary efficacy end point was the urogenital microbiological cure in the urogenital microbiological intention-to-treat population; noninferiority (NI) was assessed using a 10% NI margin. RESULTS: In the urogenital microbiological intention-to-treat population, urogenital cure rates for delafloxacin were 85.1% (194/228) versus 91.0% (91/100) for ceftriaxone (95% confidence interval, -13.18% to 1.36%). Because the lower bound of the confidence interval exceeded the prespecified -10% NI margin, delafloxacin did not demonstrate NI to ceftriaxone. Treatment failures were more often associated with N. gonorrhoeae with higher delafloxacin minimum inhibitory concentration (MIC) values. In microbiologically evaluable participants, failure occurred in 1 (0.6%) of 177 urogenital infections caused by isolates with delafloxacin MICs <0.008 µg/mL and 31 (64.6%) of 48 infections caused by isolates with delafloxacin MICs ≥0.008 µg/mL. Gastrointestinal adverse events were common with 900-mg of delafloxacin and typically included mild to moderate diarrhea, flatulence, nausea, and vomiting. The most common adverse event was diarrhea in both treatment groups. CONCLUSIONS: A single 900-mg dose of delafloxacin is not a reliable treatment of uncomplicated urogenital gonorrhea. Treatment failures were common in infections caused by N. gonorrhoeae with delafloxacin MICs ≥0.008 µg/mL. Additional testing with alternative dosing regimens could be considered.ClinicalTrials.gov Identifier: NCT02015637.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Ceftriaxone/administration & dosage , Fluoroquinolones/administration & dosage , Gonorrhea/drug therapy , Neisseria gonorrhoeae/drug effects , Administration, Oral , Adolescent , Adult , Aged , Cervix Uteri/microbiology , Equivalence Trials as Topic , Female , Gonorrhea/microbiology , Humans , Injections, Intramuscular , Male , Middle Aged , Neisseria gonorrhoeae/isolation & purification , Pharynx/microbiology , Rectum/microbiology , Treatment Outcome , Urethra/microbiology , Young Adult
12.
Proc Natl Acad Sci U S A ; 113(38): 10678-83, 2016 09 20.
Article in English | MEDLINE | ID: mdl-27601663

ABSTRACT

Maternal innate and adaptive immune responses are modulated during pregnancy to concurrently defend against infection and tolerate the semiallogeneic fetus. The restoration of these systems after childbirth is poorly understood. We reasoned that enhanced innate immune activation may extend beyond gestation while adaptive immunity recovers. To test this hypothesis, the transcriptional profiles of total peripheral blood mononuclear cells following delivery in healthy women were compared with those of nonpregnant control subjects. Interestingly, interferon-stimulated genes (ISGs) encoding proteins such as IFIT1, IFIT2, and IFIT3, as well as signaling proteins such as STAT1, STAT2, and MAVS, were enriched postpartum. Antiviral genes were primarily expressed in CD14(+) cells and could be stratified according to genetic variation at the interferon-λ3 gene (IFNL3, also named IL28B) SNP rs12979860. Antiviral gene expression was sustained beyond 6 mo following delivery in mothers with a CT or TT genotype, but resembled baseline nonpregnant control levels following delivery in mothers with a CC genotype. CT and TT IFNL3 genotypes have been associated with persistent elevated ISG expression in individuals chronically infected with hepatitis C virus. Together, these data suggest that postpartum, the normalization of the physiological rheostat controlling IFN signaling depends on IFNL3 genotype.


Subject(s)
Hepacivirus/immunology , Hepatitis C/immunology , Immunity, Innate/genetics , Intracellular Signaling Peptides and Proteins/genetics , Adaptor Proteins, Signal Transducing , Adult , Apoptosis Regulatory Proteins , Carrier Proteins/genetics , Female , Gene Expression Regulation/immunology , Genotype , Hepacivirus/genetics , Hepacivirus/pathogenicity , Hepatitis C/genetics , Hepatitis C/virology , Humans , Intracellular Signaling Peptides and Proteins/immunology , Leukocytes, Mononuclear/immunology , Leukocytes, Mononuclear/metabolism , Lipopolysaccharide Receptors/immunology , Maternal-Fetal Relations , Polymorphism, Single Nucleotide , Postpartum Period , Pregnancy , Proteins/genetics , RNA-Binding Proteins
13.
Clin Infect Dis ; 67(4): 504-512, 2018 08 01.
Article in English | MEDLINE | ID: mdl-29617982

ABSTRACT

Background: In this phase 2 study, we evaluated the efficacy and safety of oral gepotidacin, a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor, for the treatment of uncomplicated urogenital gonorrhea. Methods: Adult participants with suspected urogenital gonorrhea were enrolled and completed baseline (day 1) and test-of-cure (days 4-8) visits. Pretreatment and posttreatment urogenital swabs were collected for Neisseria gonorrhoeae (NG) culture and susceptibility testing. Pharyngeal and rectal swab specimens were collected if there were known exposures. Participants were stratified by gender and randomized 1:1 to receive a 1500-mg or 3000-mg single oral dose of gepotidacin. Results: The microbiologically evaluable population consisted of 69 participants, with NG isolated from 69 (100%) urogenital, 2 (3%) pharyngeal, and 3 (4%) rectal specimens. Microbiological eradication of NG was achieved by 97%, 95%, and 96% of participants (lower 1-sided exact 95% confidence interval bound, 85.1%, 84.7%, and 89.1%, respectively) for the 1500-mg, 3000-mg, and combined dose groups, respectively. Microbiological cure was achieved in 66/69 (96%) urogenital infections. All 3 failures were NG isolates that demonstrated the highest observed gepotidacin minimum inhibitory concentration of 1 µg/mL and a common gene mutation. At the pharyngeal and rectal sites, 1/2 and 3/3 NG isolates, respectively, demonstrated microbiological cure. There were no treatment-limiting adverse events for either dose. Conclusions: This study demonstrated that single, oral doses of gepotidacin were ≥95% effective for bacterial eradication of NG in adult participants with uncomplicated urogenital gonorrhea. Clinical Trials Registration: NCT02294682.


Subject(s)
Acenaphthenes/administration & dosage , Anti-Bacterial Agents/administration & dosage , Female Urogenital Diseases/drug therapy , Gonorrhea/drug therapy , Heterocyclic Compounds, 3-Ring/administration & dosage , Male Urogenital Diseases/drug therapy , Acenaphthenes/pharmacology , Administration, Oral , Adolescent , Adult , Aged , Anti-Bacterial Agents/pharmacology , Drug Administration Schedule , Female , Female Urogenital Diseases/microbiology , Heterocyclic Compounds, 3-Ring/pharmacology , Humans , Male , Male Urogenital Diseases/microbiology , Microbial Sensitivity Tests , Middle Aged , Neisseria gonorrhoeae/drug effects , Neisseria gonorrhoeae/isolation & purification , Pharyngeal Diseases/microbiology , Rectal Diseases/microbiology , Young Adult
14.
Gastroenterology ; 153(1): 113-122, 2017 07.
Article in English | MEDLINE | ID: mdl-28390869

ABSTRACT

BACKGROUND & AIMS: Patients with chronic hepatitis C virus (HCV) infection have high rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir. We assessed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir). METHODS: In 2 phase 3, open-label trials, patients with HCV infection who had not been treated previously with a direct-acting antiviral agent were assigned randomly to groups given sofosbuvir-velpatasvir-voxilaprevir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks. POLARIS-2, which enrolled patients infected with all HCV genotypes with or without cirrhosis, except patients with genotype 3 and cirrhosis, was designed to test the noninferiority of 8 weeks of sofosbuvir-velpatasvir-voxilaprevir to 12 weeks of sofosbuvir-velpatasvir using a noninferiority margin of 5%. POLARIS-3, which enrolled patients infected with HCV genotype 3 who had cirrhosis, compared rates of SVR in both groups with a performance goal of 83%. RESULTS: In POLARIS-2, 95% (95% confidence interval [CI], 93%-97%) of patients had an SVR to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir; this did not meet the criterion to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir, which produced an SVR in 98% of patients (95% CI, 96%-99%; difference in the stratum-adjusted Mantel-Haenszel proportions of -3.2%; 95% CI, -6.0% to -0.4%). The difference in the efficacy was owing primarily to a lower rate of SVR (92%) among patients with HCV genotype 1a infection receiving 8 weeks of sofosbuvir-velpatasvir-voxilaprevir. In POLARIS-3, 96% of patients (95% CI, 91%-99%) achieved an SVR in both treatment groups, which was significantly superior to the performance goal. Overall, the most common adverse events were headache, fatigue, diarrhea, and nausea; diarrhea and nausea were reported more frequently by patients receiving voxilaprevir. In both trials, the proportion of patients who discontinued treatment because of adverse events was low (range, 0%-1%). CONCLUSIONS: In phase 3 trials of patients with HCV infection, we did not establish that sofosbuvir-velpatasvir-voxilaprevir for 8 weeks was noninferior to sofosbuvir-velpatasvir for 12 weeks, but the 2 regimens had similar rates of SVR in patients with HCV genotype 3 and cirrhosis. Mild gastrointestinal adverse events were associated with treatment regimens that included voxilaprevir. ClinicalTrials.gov numbers: POLARIS-2, NCT02607800; and POLARIS-3, NCT02639338.


Subject(s)
Antiviral Agents/therapeutic use , Carbamates/therapeutic use , Hepatitis C, Chronic/drug therapy , Heterocyclic Compounds, 4 or More Rings/therapeutic use , Macrocyclic Compounds/therapeutic use , Sofosbuvir/therapeutic use , Sulfonamides/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Aminoisobutyric Acids , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Carbamates/administration & dosage , Carbamates/adverse effects , Cyclopropanes , Drug Therapy, Combination , Female , Heterocyclic Compounds, 4 or More Rings/administration & dosage , Heterocyclic Compounds, 4 or More Rings/adverse effects , Humans , Lactams, Macrocyclic , Leucine/analogs & derivatives , Macrocyclic Compounds/administration & dosage , Macrocyclic Compounds/adverse effects , Male , Middle Aged , Proline/analogs & derivatives , Quinoxalines , Sofosbuvir/administration & dosage , Sofosbuvir/adverse effects , Sulfonamides/administration & dosage , Sulfonamides/adverse effects , Sustained Virologic Response , Young Adult
15.
J Infect Dis ; 216(suppl_2): S427-S430, 2017 07 15.
Article in English | MEDLINE | ID: mdl-28838075

ABSTRACT

This article lays out the research priorities for Mycoplasma genitalium research agreed upon by the participants in a 2016 National Institutes of Allergy and Infectious Diseases-funded Technical Consultation focused on this organism. The state of current knowledge concerning the microbiology, epidemiology, clinical manifestations of infection, treatment, and public health significance of M. genitalium reviewed at the meeting is described in detail in the individual articles included in this supplemental edition of the Journal of Infectious Diseases. Here we summarize the points made in these articles most relevant to the formulation of the research priorities listed in this article. The most important recommendation resulting from this Technical Consultation is the initiation of clinical trials designed to determine definitively whether screening for and treatment of M. genitalium infections in women and their sexual partners improve reproductive health in women and/or prevent human immunodeficiency virus transmission.


Subject(s)
Mycoplasma Infections/diagnosis , Mycoplasma Infections/epidemiology , Mycoplasma genitalium , Public Health/trends , Research/trends , Adult , Anti-Bacterial Agents/therapeutic use , Clinical Trials as Topic , Consensus , Drug Resistance, Microbial , Female , HIV Infections/prevention & control , HIV Infections/transmission , Humans , Mycoplasma Infections/drug therapy , National Institutes of Health (U.S.) , Practice Guidelines as Topic , United States
16.
J Infect Dis ; 216(suppl_2): S420-S426, 2017 07 15.
Article in English | MEDLINE | ID: mdl-28838079

ABSTRACT

Although Mycoplasma genitalium is increasingly recognized as a sexually transmitted pathogen, at present there is no defined public health response to this relatively newly identified sexually transmitted infection. Currently available data are insufficient to justify routinely screening any defined population for M. genitalium infection. More effective therapies, data on acceptability of screening and its impact on clinical outcomes, and better information on the natural history of infection will likely be required before the value of potential screening programs can be adequately assessed. Insofar as diagnostic tests are available or become available in the near future, clinicians and public health agencies should consider integrating M. genitalium testing into the management of persons with sexually transmitted infection (STI) syndromes associated with the infection (ie urethritis, cervicitis, and pelvic inflammatory disease) and their sex partners. Antimicrobial-resistant M. genitalium is a significant problem and may require clinicians and public health authorities to reconsider the management of STI syndromes in an effort to prevent the emergence of ever more resistant M. genitalium infections.


Subject(s)
Mycoplasma Infections/epidemiology , Mycoplasma genitalium/isolation & purification , Public Health , Sexually Transmitted Diseases, Bacterial/epidemiology , Anti-Bacterial Agents/therapeutic use , Drug Resistance, Bacterial , Female , Humans , Male , Mycoplasma Infections/complications , Mycoplasma Infections/drug therapy , Sexual Partners , Sexually Transmitted Diseases, Bacterial/complications , Sexually Transmitted Diseases, Bacterial/microbiology
18.
Clin Infect Dis ; 64(11): 1573-1581, 2017 Jun 01.
Article in English | MEDLINE | ID: mdl-28449115

ABSTRACT

BACKGROUND.: Hepatitis C virus (HCV) infection is the most common chronic blood-borne infection in the United States and a leading cause of morbidity and mortality. Previous analyses of the US National Health and Nutrition Examination Survey (NHANES) indicated approximately 3.6 million noninstitutionalized persons with antibody to HCV (anti-HCV). However, state-level prevalence remains less understood and cannot be estimated reliably from NHANES alone. METHODS.: We used 3 publicly available government data sources to estimate anti-HCV prevalence in each US state among noninstitutionalized persons aged ≥18 years. A small-area estimation model combined indirect standardization of NHANES-based prevalence with logistic regression modeling of mortality data, listing acute or chronic HCV infection as a cause of death, from the National Vital Statistics System during 1999-2012. Model results were combined with US Census population sizes to estimate total number and prevalence of persons with antibody to HCV in 2010. RESULTS.: National anti-HCV prevalence was 1.67% (95% confidence interval [CI], 1.53-1.90), or 3 911 800 (95% CI, 3 589 400- 4 447 500) adults in 2010. State-specific prevalence ranged from 0.71% (Illinois) to 3.34% (Oklahoma). The West census region had the highest region-specific prevalence (2.14% [95% CI, 1.96-2.48]); 10 of 13 states had rates above the national average. The South had the highest number of persons with anti-HCV (n = 1561600 [95% CI, 1 427 700-1 768 900]). The Midwest had the lowest region-specific prevalence (1.14% [95% CI, 1.04%-1.30%]). CONCLUSIONS.: States in the US West and South have been most impacted by hepatitis C. Estimates of HCV infection burden are essential to guide policy and programs to optimally prevent, detect, and cure infection.


Subject(s)
Hepatitis C Antibodies/blood , Hepatitis C, Chronic/epidemiology , Hepatitis C/epidemiology , Adult , Aged , District of Columbia/epidemiology , Epidemiological Monitoring , Female , Hepacivirus/genetics , Hepacivirus/immunology , Hepacivirus/isolation & purification , Hepatitis C/immunology , Hepatitis C/mortality , Hepatitis C/virology , Hepatitis C, Chronic/virology , Humans , Logistic Models , Male , Middle Aged , Nutrition Surveys , Prevalence , RNA, Viral/blood , Risk Factors , United States/epidemiology , Young Adult
19.
Sex Transm Dis ; 44(1): 13-16, 2017 01.
Article in English | MEDLINE | ID: mdl-27898574

ABSTRACT

BACKGROUND: The recommended regimen for treating uncomplicated gonorrhea has changed over time, due to the emergence of antimicrobial resistance. We assessed physician knowledge of the recommendation for treating uncomplicated urogenital gonorrhea in adolescents and adults using ceftriaxone and azithromycin dual therapy. METHODS: We analyzed DocStyles 2015 survey data from 1357 primary care physicians practicing for at least 3 years who provided screening, diagnosis, or treatment for sexually transmitted diseases to one or more patients in an average month. Logistic regression and χ analyses were used to identify factors associated with knowledge of dual therapy. RESULTS: Among the options of treatment with ceftriaxone alone, azithromycin alone, both of these, or spectinomycin plus levofloxacin, 64% of physicians correctly preferred ceftriaxone plus azithromycin. Knowledge of the recommended dual therapy decreased with increasing years of practice, ranging from 74% among physicians with 3-9 years of practice to 57% among those practicing for ≥24 years (adjusted odds ratio, ORa, for ≥24 vs 3-9 years of practice, 0.50; 95% confidence interval [CI], 0.35-0.70). Knowledge of dual therapy decreased with higher socioeconomic status of patients (ORa for high income vs poor/lower middle income patients, 0.47; 95% CI, 0.32-0.69). Physicians who pursued continuing medical education using journals, podcasts, and government health agencies were more likely to report dual therapy than those who did not use these sources (ORa, 2.09; 95% CI, 1.31-3.33). CONCLUSIONS: Knowledge of the recommended regimen for treating gonorrhea decreased with increasing years of practice and with higher socioeconomic status of patients.


Subject(s)
Clinical Protocols , Gonorrhea/drug therapy , Health Knowledge, Attitudes, Practice , Physicians, Primary Care/psychology , Practice Patterns, Physicians' , Adult , Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , Ceftriaxone/therapeutic use , Chi-Square Distribution , Drug Therapy, Combination , Female , Humans , Levofloxacin/therapeutic use , Logistic Models , Male , Middle Aged , Primary Health Care/methods , Spectinomycin/therapeutic use
20.
MMWR Recomm Rep ; 64(RR-03): 1-137, 2015 Jun 05.
Article in English | MEDLINE | ID: mdl-26042815

ABSTRACT

These guidelines for the treatment of persons who have or are at risk for sexually transmitted diseases (STDs) were updated by CDC after consultation with a group of professionals knowledgeable in the field of STDs who met in Atlanta on April 30-May 2, 2013. The information in this report updates the Sexually Transmitted Diseases Treatment Guidelines, 2010 (MMWR Recomm Rep 2010;59 [No. RR-12]). These updated guidelines discuss 1) alternative treatment regimens for Neisseria gonorrhoeae; 2) the use of nucleic acid amplification tests for the diagnosis of trichomoniasis; 3) alternative treatment options for genital warts; 4) the role of Mycoplasma genitalium in urethritis/cervicitis and treatment-related implications; 5) updated HPV vaccine recommendations and counseling messages; 6) the management of persons who are transgender; 7) annual testing for hepatitis C in persons with HIV infection; 8) updated recommendations for diagnostic evaluation of urethritis; and 9) retesting to detect repeat infection. Physicians and other health-care providers can use these guidelines to assist in the prevention and treatment of STDs.


Subject(s)
Sexually Transmitted Diseases/therapy , Complementary Therapies , Condylomata Acuminata/therapy , Counseling , Female , Gonorrhea/therapy , HIV Infections/complications , Hepatitis C/diagnosis , Humans , Male , Mass Screening , Mycoplasma genitalium/pathogenicity , Nucleic Acid Amplification Techniques , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines , Recurrence , Sexually Transmitted Diseases/prevention & control , Transgender Persons , Trichomonas Infections/diagnosis , Urethritis/diagnosis , Urethritis/microbiology , Urethritis/therapy , Uterine Cervicitis/microbiology , Uterine Cervicitis/therapy
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